Why it was recalled
Discoloration; due to prolonged heat exposure.
Product description
ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3
Lot numbers, UPCs & expiration codes
Lot Number:Expiry Date - 0804.182B-1:07/14; 0804.183B-1:07/14; 0804.185A-1:08/14; 0804.186B-1:08/14; 0804.187B-1:08/14; 0804.210A-1:12/14; 0804.212A-1:12/14; 0804.213A-1:12/14; 0804.214A-1:12/14; 0804.216B-1:12/14; 0804.223B-1:02/15 0804.225B-1:03/15
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1426-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 19, 2013
- FDA report date
- Jul 16, 2014
- Quantity
- 72,046 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ferring Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1426-2014, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66604
- Address
- 4 Gatehall Dr Fl 3rd
- Code information
- Lot Number:Expiry Date - 0804.182B-1:07/14; 0804.183B-1:07/14; 0804.185A-1:08/14; 0804.186B-1:08/14; 0804.187B-1:08/14; 0804.210A-1:12/14; 0804.212A-1:12/14; 0804.213A-1:12/14; 0804.214A-1:12/14; 0804.216B-1:12/14; 0804.223B-1:02/15 0804.225B-1:03/15
- Postal code
- 07054-4518
- Report date
- Jul 16, 2014
- Product type
- Drugs
- Recall number
- D-1426-2014
- Classification
- Class III
- Recalling firm
- Ferring Pharmaceuticals Inc
- Product quantity
- 72,046 cartons
- Termination date
- Feb 19, 2015
- Reason for recall
- Discoloration; due to prolonged heat exposure.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3
- Distribution pattern
- Nationwide.
- Recall initiation date
- Sep 19, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 9, 2014